Polarcup Instrument Tray Lid
- Primary DI
- 09421028114844
- Brand
- Polarcup Instrument Tray Lid
- Company
- ENZTEC LIMITED
- Model
- 35130082
- Catalog number
- 35130082
- Device description
- Tray/case used to hold other medical devices
- Published
- 2023-02-17
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| FSM | Tray, Surgical, Instrument |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 09421028114844 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 09421028114844 | 09421028114844 | 9421028114844 |
GMDN Terms
| Term | Definition |
|---|
| Instrument tray, reusable | A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 592616445
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 09421038412220 | Enztec XR Trinket M8X1.0-01 | 4252-2449 | 4252-2449 | 2026-03-13 |
| 09421038412145 | Cup reamer handle, offset, Z/H, locking | 9209-1301 | 9209-1301 | 2026-03-09 |
| 09421038412152 | Offset coupling, Z/H | 9209-1306 | 9209-1306 | 2026-03-09 |
| 09421038412169 | Offset drive train, locking | 9209-1303 | 9209-1303 | 2026-03-09 |
| 09421038412176 | Short Offset Cover – United | 9209-1307 | 9209-1307 | 2026-03-09 |
| 09421038412183 | Handle – United | 9209-1305 | 9209-1305 | 2026-03-09 |
| 09421038412299 | Cup reamer handle, offset, AO, locking | 9209-1311 | 9209-1311 | 2026-03-09 |
| 09421038412305 | Offset coupling, AO | 9209-1313 | 9209-1313 | 2026-03-09 |
| 09421038412312 | Cup reamer handle, offset, AO, open | 9209-1312 | 9209-1312 | 2026-03-09 |
| 09421038412329 | Offset drive train, open | 9209-1304 | 9209-1304 | 2026-03-09 |
| 09421038412671 | Cup reamer handle, offset, Z/H, open | 9209-1302 | 9209-1302 | 2026-03-09 |
| 09421038411865 | Enztec Modular OCI X | 4251-3101 | 4251-3101 | 2026-02-27 |
| 09421038411889 | Adj Dist Fem Alignment Guide – Cartilage | 4240-7700 | 4240-7700 | 2026-02-27 |
| 09421038411896 | Adj Dist Fem Alignment Guide – Paddle | 4240-7701 | 4240-7701 | 2026-02-27 |
| 09421038411902 | Sagittal Alignment Connector - Pivot | 4240-7705 | 4240-7705 | 2026-02-27 |
| 09421038411919 | Sagittal Alignment Connector - Pivot with Fan | 4240-7706 | 4240-7706 | 2026-02-27 |
| 09421038411926 | Dist Fem Cut Block Connector – 8mm | 4240-7710 | 4240-7710 | 2026-02-27 |
| 09421038411933 | Dist Fem Cut Block Connector – 9mm | 4240-7711 | 4240-7711 | 2026-02-27 |
| 09421038411940 | Dist Fem Cut Block Connector – 10mm | 4240-7712 | 4240-7712 | 2026-02-27 |
| 09421038411957 | Dist Fem Cut Block Slot Connector – 8mm | 4240-7725 | 4240-7725 | 2026-02-27 |
Other Devices Sharing Product Codes